The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
Inha University Hospital
Incheon, South Korea
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)
Time frame: 12 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 12 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
Time frame: 12 weeks
Proportion of subjects whose CA-SMFRS (Clinician-Assessed Submental Fat Rating Scale) score changed
Proportion of subjects whose CA-SMFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP, Minimum value: 0 (best outcome) / Maximum value: 4 (worst outcome)
Time frame: 4 weeks
Proportion of subjects whose PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score changed
Proportion of subjects whose PA-MFRS decreased 1, 2 points or more compared the 4 weeks after the last administration day to before administration of the IP , Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
Time frame: 4 weeks
PA-SMFIS (Patient Assessed-Submental Fat Impact Scale)
Change PA-SMFIS (Patient Assessed-Submental Fat Impact Scale) score compared 4 to 12 weeks after the last administration of the IP, Minimum value: 0 (worst outcome) / Maximum value: 10 (best outcome)
Time frame: 4 and 12 weeks
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Measuring submental fat volume by MRI (magnetic resonance imaging)
Confirmation the volume of submental fat compared the 12 weeks after the last administration to before administration of the IP measured by MRI (Number of Participants: approximately 120)
Time frame: 12 weeks
Satisfaction Evaluation by the subject
A score of 5 (slightly satisfied) or higher in the subject satisfaction evaluation at 4 and 12 weeks after the last administration to before administration of the IP
Time frame: 4 and 12 weeks